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RECRUITING Phase 3 ClinicalTrials.gov

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Sponsor: Astellas Pharma Global Development, Inc. • ClinicalTrials.gov ID: NCT07409272

Registry updated: 2026-09-22
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Description

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. The first treatment that people usually receive is chemotherapy. At the time this study started, some of the main standard chemotherapies for pancreatic cancer were mFOLFIRINOX or NALIRIFOX. Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with pancreatic cancer have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation. This study is about setidegrasib given with chemotherapy in people with pancreatic cancer who have the KRAS G12D mutation. Before setidegrasib can become an approved treatment, clinical studies need to be completed to understand how it works and how safe it is. The main aim is to learn if people who are given setidegrasib with chemotherapy live for longer than people who are given placebo with chemotherapy. Other aims are to learn if setidegrasib delays the cancer and symptoms returning, how the body processes setidegrasib, and its safety, when given with chemotherapy. People in this study will be adults with metastatic pancreatic cancer with the G12D mutation in their KRAS gene. Surgery or radiotherapy will not be an option to cure their cancer. People cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or have recently had some other cancers that required treatment. In this study, people are given either setidegrasib with mFOLFIRINOX or NALIRIFOX chemotherapy, or a placebo with mFOLFIRINOX or NALIRIFOX chemotherapy. Whether people receive setidegrasib or placebo is decided by chance. The study doctor decides which chemotherapy (mFOLFIRINOX or NALIRIFOX) people receive. People will only receive NALIRIFOX chemotherapy (with setidegrasib or placebo) after the safety of setidegrasib with NALIRIFOX chemotherapy has been confirmed in another ongoing setidegrasib study. All of the study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study.

Interventions

  • Setidegrasib (Drug)
    Intravenous infusion
  • Oxaliplatin (Drug)
    Intravenous infusion
  • Leucovorin (Drug)
    Intravenous infusion
  • Irinotecan (Drug)
    Intravenous infusion
  • fluorouracil (Drug)
    Intravenous infusion
  • liposomal irinotecan (Drug)
    Intravenous infusion
  • Placebo (Drug)
    Intravenous Infusion

Eligibility criteria

Inclusion Criteria: * Participant has histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation based on local or central testing (confirmation of a participant's positive KRAS G12D mutation result must be available prior to randomization). * Participant has no option for surgical resection or radiotherapy with curative intent. * Participant consents to and provides a baseline tumor tissue specimen for the study during screening. The sample must meet the requirements described in the laboratory manual and the tumor sample guidance. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days prior to randomization. * Participant has adequate organ function as indicated by the following laboratory values within 7 days prior to randomization (if a participant has received a recent blood transfusion, the latest laboratory tests must be obtained ≥ 14 days after any blood transfusion). The laboratory values prior to the initiation of the first dose of setidegrasib/placebo (or mFOLFIRINOX/NALIRIFOX, if chemotherapy is administered during the screening period) should be used to determine eligibility. Participants who receive mFOLFIRINOX/NALIRIFOX during the screening period must meet these criteria within 7 days prior to the start of on-treatment chemotherapy (i.e., C1D1). * Participant agrees not to participate in another interventional study while receiving study intervention in the present study (participant who is currently in the follow-up period of an interventional clinical trial is allowed). Exclusion Criteria: * Participant has neuroendocrine, acinar pancreatic carcinoma or pancreatic cancer with squamous/adenosquamous features. * Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed. * Participant has chronic inflammatory bowel disease, bowel obstruction and/or severe uncontrolled diarrhea. * Participant has peripheral sensory neuropathy with functional impairment. * Participant has ascites and/or pleural effusion that require invasive interventions within 30 days prior to randomization or have an indwelling drainage catheter. * Participant has symptomatic pulmonary embolism or pulmonary embolism not being treated with anticoagulation. * Participant has a history of interstitial lung disease or pulmonary fibrosis. * Participant has uncontrolled seizure disorder or refractory to antiepileptics. * Participant has known homozygous uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism. * Participant has had a myocardial infarction, unstable angina or coronary artery bypass surgery within 6 months prior to randomization or currently has an uncontrolled illness including but not limited to symptomatic congestive heart failure, clinically significant cardiac disease (e.g., cardiomyopathy, infiltrative cardiac disease, etc.), unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker or long QT interval (QT) syndrome. * Participant has received any prior systemic therapy for their metastatic PDAC (except with up to 2 doses \[i.e., 28 days; 1 cycle\] of mFOLFIRINOX or NALIRIFOX during the screening period. If a participant received \[neo\]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose of the \[neo\]adjuvant therapy). * Participant has had prior treatment with a KRAS G12D-targeted agent. * Participant has a corrected QT interval by Fridericia (QTcF) (single electrocardiogram \[ECG\]) \> 470 msec during the screening period.

Conditions

Pancreatic Cancer Metastatic Pancreatic Cancer Metastatic Pancreatic Adenocarcinoma

Locations

  • University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States
  • Mercy Cancer Center — Fort Smith, Arkansas, United States
  • Crosson Cancer Institute at Providence St. Jude Medical Center in Fullerton — Fullerton, California, United States
  • UCI Health - Irvine — Irvine, California, United States
  • Cedars-Sinai - Cedars-Sinai Medical Center — Los Angeles, California, United States
  • Hoag Mem Hosp Presbyterian — Newport Beach, California, United States
  • UC Irvine Health-Chao Family Comprehensive Cancer Center — Orange, California, United States
  • Hartford Healthcare — Hartford, Connecticut, United States
  • Baptist MD Anderson Cancer Institute — Jacksonville, Florida, United States
  • Baptist Health Medical Group Oncology — Miami, Florida, United States
  • Mount Sinai Medical Center - Miami Beach — Miami Beach, Florida, United States
  • Piedmont Healthcare - Piedmont Physicians Medical Oncology Atlanta — Atlanta, Georgia, United States
  • Indiana University Health - Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States
  • Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health Care — Edgewood, Kentucky, United States
  • University of Maryland School - Division of Hematology/Oncology — Baltimore, Maryland, United States
  • University of Michigan Health - University of Michigan Medical Center — Ann Arbor, Michigan, United States
  • Allina Health Cancer Institute - Hematology Cancer Care Services — Minneapolis, Minnesota, United States
  • HealthPartners Frauenshuh Cancer Center — Saint Louis Park, Minnesota, United States
  • HealthPartners Cancer Center at Regions Hospital — Saint Paul, Minnesota, United States
  • Mercy CH Chub O'Reilly Cancer Center — Springfield, Missouri, United States
  • The Alvin J. Siteman Cancer Center - Center for Advanced Med — St Louis, Missouri, United States
  • Mercy David C. Pratt Cancer Center - St. - Mercy Research - David C. Pratt Cancer Center — St Louis, Missouri, United States
  • Saint Joseph Hospital - Cancer Centers - St. Vincent Frontier Cancer Center — Billings, Montana, United States
  • Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
  • Memorial Sloan Kettering - Hackensack - Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center - Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Atlantic Health - Overlook Medical Center — Morristown, New Jersey, United States
  • Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial Sloan Kettering Westchester — Harrison, New York, United States
  • NYU Long Island Mineola — Mineola, New York, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • White Plains Hospital Center for Cancer Care - Oncology — White Plains, New York, United States
  • Facilities Design and Construction - Energy Advancement and Innovation Center — Columbus, Ohio, United States
  • Mercy Hospital Oklahoma City - Mercy Coletta Cancer Center - Oklahoma City — Oklahoma City, Oklahoma, United States
  • Oregon Health & Science University - OHSU Knight Cancer Institute — Portland, Oregon, United States
  • AGH Singer Research Institute — Pittsburgh, Pennsylvania, United States
  • Brown University Health Cancer Institute - Division of Hematology/Oncology — Providence, Rhode Island, United States
  • UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
  • Houston Methodist Office of Graduate - Houston Methodist Neal Cancer Center at Texas Medical Center — Houston, Texas, United States
  • Utah Cancer Specialists — Salt Lake City, Utah, United States
  • UVA Emily Couric Cancer Center — Charlottesville, Virginia, United States
  • Inova Schar Cancer Institute Clinical Trials — Fairfax, Virginia, United States
  • Virginia Mason Franciscan Health - Virginia Mason Medical Center — Seattle, Washington, United States
  • Fred Hutchinson Cancer Center - Advanced Cancer Research Group — Seattle, Washington, United States
  • Fudan University Shanghai Cancer Center - Xuhui Campus — Shanghai, Shanghai Municipality, China
  • National Cancer Center Hospital East — Kashiwa, Chiba, Japan
  • Chugoku-Shikoku Group - Shikoku Cancer Center — Matsuyama, Ehime, Japan
  • Kyushu Group - Kyushu Cancer Center — Fukuoka, Fukuoka, Japan
  • Nara Medical University Hospital — Kashihara-shi, Nara, Japan
  • Kindai University Hospital — Sakai, Osaka, Japan
  • The University of Osaka Hospital — Suita, Osaka, Japan
  • The University of Tokyo Hospital — Bunkyo-ku, Tokyo, Japan
  • Japanese Foundation for Cancer Research - The Cancer Institute Hospital of JFCR — Koto, Tokyo, Japan
  • Yamaguchi University Hospital — Ube-shi, Yamaguchi, Japan
  • Aichi Cancer Center — Nagoya, Japan
  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute — Osaka, Japan
  • Keio University Hospital — Tokyo, Japan
  • Site KR82004 — Cheongju-si, South Korea
  • Site KR82015 — Incheon, South Korea
  • Site KR82006 — Seongnam-si, South Korea
  • Site KR82002 — Seoul, South Korea
  • Site KR82010 — Seoul, South Korea
  • Site KR82012 — Seoul, South Korea
  • Site KR82013 — Seoul, South Korea
  • Site KR82014 — Suwon, South Korea
  • Site TW88603 — Taichung, Taiwan
  • Site TW88605 — Taipei, Taiwan
  • Site GB44001 — Cambridge, United Kingdom
  • Site GB44007 — Cottingham, United Kingdom
  • Site GB44010 — Ipswich, United Kingdom
  • Site GB44019 — London, United Kingdom
  • Site GB44032 — London, United Kingdom
  • Site GB44031 — Maidstone, United Kingdom
  • Site GB44020 — Sutton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record